Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
- It is to evaluate the safety and effectiveness of a lasertinib(LECLAZA) single drug in a actual medical environment for patients
- Primary Purpose: Progression-free survival (PFS)
- Secondary Purpose:
- Objective response rate
- Time to treatment failure
- Adverse event (AE), serious adverse event (SAE), and adverse event of special interest (AESI)
- Severity of (S)AE
- duration of response (DoR)
- Overall survival (OS)
- Intravenous Progressive Survival Period (Intracranial PFS)
- Relative dose intensity
- Research Design : a Multi-Center Prospective and Restrospective Cohort Study
详细描述
□ the purpose of the study The study aims to explore the safety, efficacy and resistance of test drugs in patients with local progressive or metastatic epithelial growth factor T790M mutant non-small cell lung cancer who have been treated with epithelial growth factor receptor tyrosine kinase inhibitors.
This study is conducted in Korea. About 600 patients will be monitored until the first occurrence of disease progression, withdrawal of consent, failure of follow-up investigation, and death.
□ Research Procedures and Information Gathering Items There are no additional procedures performed by participating in this study and information on safety and effectiveness during the administration of Rexhraza will be followed up in routine care situations.
The information you will receive when you participate in this study is as follows.
- Subject characteristics, including age, gender, and race
- T790M Positive Mutation Status Results and Types of Tests Performed and Receptors
- a related medical history
- a physical examination
- disease characteristics
- history of chemotherapy
- associated concomitant medications
- administration of a test drug
- Safety and effectiveness
- Resistance mechanism in plasma circulation tumor DNA
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective cohort
- •adults over the age of 19
- •Easter Cooperative Oncology Group performance 0-4
- •Patients who are eligible for or are being treated for test medication as per permit: patients with NSCLC with local progressive or metastatic EGFR T790M mutation who have previously been treated with Generation 1 or Generation 2 EGFR TKI
- •EGFR T790M mutation allows for all results identified in tumor tissue or plasma
- •Patients with brain MR within 3 months of study participation
- •Rectrospective cohort
- •adults over the age of 19
- •Patients who are already using the test drug according to the domestic authorization of the test drug
排除标准
- •Patients who have a history of hypersensitivity to test drugs or drugs of similar chemical structure or similar family to those of test drugs
- •Pregnant women or lactating women
- •Patients participating in other interventional clinical studies
研究组 & 干预措施
Prospective cohort
-
Inclusion criteria
-
adults over the age of 19
-
Easter Cooperative Oncology Group performance 0-4
-
Patients who are eligible for or are being treated for test medication as per permit: patients with NSCLC with local progressive or metastatic EGFR T790M mutation who have previously been treated with Generation 1 or Generation 2 EGFR TKI
-
EGFR T790M mutation allows for all results identified in tumor tissue or plasma
-
Patients with brain MR within 3 months of study participation
-
After obtaining a consent form for research participation, follow-up and monitoring survival information and safety information. Survival follow-up of prospective cohorts will be followed up to the point of first occurrence during disease progression, withdrawal of consent, failure of follow-up investigation, and death.
干预措施: Lazertinib (Drug)
Restrospective cohort
-
Inclusion criteria
-
adults over the age of 19
-
Patients who are already using the lazertinib according to the domestic authorization of lazertinib(This includes when participants receive interventions as part of routine medical care)
-
Survival information is monitored after the time when the consent form for participation in the study is obtained. Survival follow-up of retrospective cohorts will be followed up to the point of first occurrence during disease progression, withdrawal of consent, failure of follow-up investigation, and death
干预措施: Lazertinib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Through study completion, an average of 3 years
Progression-free survival (PFS) is defined as the time from study enrollment until objective disease progression or death.
次要结局
- Duration of response (DoR)(Through study completion, an average of 3 years)
- Intracranial Progression-free survival (Intracranial PFS)(Through study completion, an average of 3 years)
- Objective response rate (ORR)(Through study completion, an average of 3 years)
- Time to treatment failure (TTF)(Through study completion, an average of 3 years)
- Relative dose intensity(Through study completion, an average of 3 years)
- Overall survival (OS)(Through study completion, an average of 3 years)
研究者
Jin Seok Ahn, MD
Professor
Samsung Medical Center